Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Not Applicable

• Conditions: Post Vitrectomy State; Recurrent Diabetic Vitreous Hemorrhage

• Registration Number: NCT00300014
• Lead Sponsor: Asan Medical Center

Brief Summary

The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

Detailed Description

Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position.

We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Study Completion: 2007-05
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-12
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Previous vitrectomy due to proliferative diabetic retinopathy
• Recurrent diabetic vitreous hemorrhage

Exclusion Criteria

• Monocular vision
• Uncontrollable intraocular pressure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
day 1 : intraocular pressure, biomicroscope exam, fundus exam
day 7 : intraocular pressure, biomicroscope exam, fundus exam
2 weeks : intraocular pressure, biomicroscope exam, fundus exam
4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
2 months : intraocular pressure, biomicroscope exam, fundus exam
3months : intraocular pressure, biomicroscope exam, fundus exam
6 months : intraocular pressure, biomicroscope exam, fundus exam

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of